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Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity (UATC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417816
Recruitment Status : Terminated (At the request of the Ethical Committee)
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Dominique Hansen, Hasselt University

Brief Summary:
The addition of ultrasound-induced adipose tissue cavitation (UATC) at the level of the abdominal subcutaneous adipose tissue may seem relevant as an additive treatment option to exercise intervention in individuals with obesity. However, whether individuals with obesity who participate in an exercise intervention and additionally undergo UATC, are more likely to develop a metabolically healthy phenotype, as opposed to subjects with obesity undergoing exercise training or UATC only, remains to be studied. Therefore, the first aim of this study is to examine the impact of combined UATC during exercise intervention on abdominal subcutaneous and whole-body adipose tissue mass, quality of life and cardiometabolic risk in individuals with abdominal obesity.

Condition or disease Intervention/treatment Phase
Obesity Other: Exercise training intervention with ultrasound induced adipose tissue cavitation Other: Exercise training intervention without ultrasound induced adipose tissue cavitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Ultrasound-induced Adipose Tissue Cavitation: Effects on Cardiometabolic Risk and Body Composition in Persons With Obesity
Actual Study Start Date : April 15, 2018
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise training + adipose tissue cavitation Other: Exercise training intervention with ultrasound induced adipose tissue cavitation
Exercise training intervention with ultrasound induced adipose tissue cavitation

Sham Comparator: Exercise training + sham procedure Other: Exercise training intervention without ultrasound induced adipose tissue cavitation
Exercise training intervention with ultrasound induced adipose tissue cavitation




Primary Outcome Measures :
  1. Body composition [ Time Frame: baseline ]
    DEXA scan (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)

  2. Body composition [ Time Frame: week 12 ]
    DEXA scan (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)

  3. Fasting blood sample [ Time Frame: Baseline ]
    (glycated haemoglobin)

  4. Fasting blood sample [ Time Frame: week 12 ]
    (glycated haemoglobin)

  5. lipid profile [ Time Frame: Baseline ]
    total LDL, HDL, triglycerides

  6. lipid profile [ Time Frame: week 12 ]
    total LDL, HDL, triglycerides

  7. kidney function [ Time Frame: Baseline ]
    urea, creatinine

  8. kidney function [ Time Frame: week 12 ]
    urea, creatinine

  9. inflammation [ Time Frame: Baseline ]
    CRP

  10. inflammation [ Time Frame: week 12 ]
    CRP

  11. Bloodpressure [ Time Frame: Baseline ]
    systolic and diastolic blood pressure

  12. Bloodpressure [ Time Frame: Week 12 ]
    systolic and diastolic blood pressure

  13. oral glucose tolerance test [ Time Frame: Baseline ]
    glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load

  14. oral glucose tolerance test [ Time Frame: week 12 ]
    glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load


Secondary Outcome Measures :
  1. Overall physical fitness [ Time Frame: Baseline ]
    Maximal oxygen uptake (during cardiopulmonary exercise testing)

  2. Overall physical fitness [ Time Frame: week 12 ]
    Maximal oxygen uptake (during cardiopulmonary exercise testing)

  3. Overall physical fitness [ Time Frame: Baseline ]
    Maximal resistance (during cardiopulmonary exercise testing)

  4. Overall physical fitness [ Time Frame: week 12 ]
    Maximal resistance (during cardiopulmonary exercise testing)

  5. Overall physical fitness [ Time Frame: Baseline ]
    Maximal heart rate (measured by electrocardiogram)

  6. Overall physical fitness [ Time Frame: week 12 ]
    Maximal heart rate (measured by electrocardiogram)

  7. SF-36 questionaire [ Time Frame: Baseline ]
    Quality of Life questionaire, a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status

  8. SF-36 questionaire [ Time Frame: week 12 ]
    Quality of Life questionaire, a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status

  9. Food intake [ Time Frame: Baseline ]
    3-day food diary

  10. Food intake [ Time Frame: week 12 ]
    3-day food diary



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male/female (1:1),
  • age 18-65 y,
  • abdominal obesity (waist circumference >102cm or >88cm) -

Exclusion Criteria:

  • involvement in dietary or exercise intervention in the last year,
  • intake of any medication,
  • clinically diagnosed diseases (cardiovascular disease, hypertension, venous thromboses blood diseases, presence of a pacemaker/defibrillator, brain or nervous system diseases, kidney, thyroid or liver disease, chronic inflammatory diseases, cancer, osteoporosis and epilepsy).
  • Persons with a pregnancy,
  • a recent bone injury or the presence of a metal prothese

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417816


Locations
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Belgium
Hasselt University
Diepenbeek, Belgium, 3590
Sponsors and Collaborators
Hasselt University
Investigators
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Principal Investigator: Dominique Hansen, prof. dr. Hasselt University
Study Chair: Kenneth Verboven, dr. Hasselt University
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Responsible Party: Dominique Hansen, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT04417816    
Other Study ID Numbers: UATC-001
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms